(138 days)
JUELLCure Soft is intended for use as a permanent soft relining for total and partial dentures
- . To relieve pressure from pressure points
- To dam the palatal vibrating line ●
- . In cases of flabby ridge and/or insufficient adhesion
- . To cushion sharp-edged alveolar processes
JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
The provided text describes the 510(k) summary for the JUELLCure Soft device, which is a soft impression material for dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel SC.
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for JUELLCure Soft are based on demonstrating equivalence to the predicate device, Ufi Gel SC, across chemical composition and key physical properties.
| Test Item | Acceptance Criteria (Equivalent to Ufi Gel SC) | JUELLCure Soft Performance |
|---|---|---|
| Monomer Matrix (Base) | 70-80 % | 70-80 % |
| Rheologic Modifier (Base) | 15-30 % | 15-30 % |
| Catalyst (Base) | 0.1-0.5 % | 0.1-0.5 % |
| Colorant (Base) | <0.1 % | <0.1 % |
| Co-Monomer (Base) | 5-10 % | 5-10 % |
| Monomer Matrix (Glazing Base) | 80-90 % | 80-90 % |
| Rheologic Modifier (Glazing Base) | 10-20 % | 10-20 % |
| Catalyst (Glazing Base) | 0.1-0.5 % | 0.1-0.5 % |
| Monomer Matrix (Glazing Catalyst) | 60-70 % | 60-70 % |
| Rheologic Modifier (Glazing Catalyst) | 20-30 % | 20-30 % |
| Stabilizer (Glazing Catalyst) | 8-15 % | 8-15 % |
| Monomer Matrix (Entire mix, likely) | 70-85 % | 70-85 % |
| Rheologic Modifier (Entire mix, likely) | 15-20 % | 15-20 % |
| Stabilizer (Entire mix, likely) | 0.1-0.5 % | 0.1-0.5 % |
| Co-Monomer (Entire mix, likely) | 2-5% | 2-5% |
| Surface hardness (Shore hardness A) | 26.3 | 26.3 |
| Adhesion to dentures | 190 N | 190 N |
| Working time | 201 s | 201 s |
Study Proving Device Meets Acceptance Criteria:
The study described is a bench testing comparison of the JUELLCure Soft with the predicate device, Ufi Gel SC. The stated goal is to demonstrate "substantial equivalence" based on "indications, composition, and testing results."
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for the bench tests (surface hardness, adhesion, working time). It only provides the resulting performance values. It does not mention any clinical test sets with patient data. The data provenance is implied to be from the manufacturer's internal testing. There is no information about country of origin or whether it's retrospective or prospective, as it's a materials science test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a material, and its performance is evaluated through physical and chemical testing, not by expert interpretation of patient data. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation is based on objective material property measurements, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a material for dental use, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the chemical composition, the ground truth is the chemical analysis of the material and its components. For the physical properties (surface hardness, adhesion, working time), the ground truth is the objectively measured value obtained through standardized testing methods, comparing it directly to the reported values of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a medical device material, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
KIII78
510k Summary
SEP 1 2 2011 July 13, 2011
Trade Name: JUELLCure Soft
Common Name: soft impression material
Company Contact:
John Roderick, Operations Manager Juell Dental 2401 N. Commerce Ardmore, OK 73401 (580) 798-4414
Device Classification: resin, denture, relining, rebasing
Device CFR Section: 21 CFR 872.3760
FDA Device Class: Class II
FDA Product Code: EBI
Classification Panel: Dental
Device Description: JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
Indications for Use:
JUELL Soft Cure is intended for use as a permanent soft relining for total and partial dentures
- . To relieve pressure from pressure points
- To dam the palatal vibrating line ●
- . In cases of flabby ridge and/or insufficient adhesion
- . To cushion sharp-edged alveolar processes
Testing
The working time and setting time were determined for the Soft Cure base, catalyst, glazing base, and glazing catalyst. The surface hardness (Shor hardness A), and adhesion to dentures was determined.
Predicate Device: Ufi Gel SC, K974772, VOCO GmbH, Germany
{1}------------------------------------------------
511178
Substantial Equivalence
The material composition of Ufi Gel SC and Juel Soft Cure are very similar. The indications for use are the same. The surface hardness, adhesion time and working time are the same.
| Function | JUELL Soft Cure | Ufi Gel SC |
|---|---|---|
| Monomer Matrix | 70-80 % | 70-80 % |
| Rheologic Modifier | 15-30 % | 15-30 % |
| Catalyst | 0,1-0,5 % | 0,1-0,5 % |
| Monomer Matrix | 70-80 % | 70-80 % |
| Rheologic Modifier | 15-30 % | 15-30 % |
| Colorant | <0.1 % | <0.1 % |
| Co-Monomer | 5-10 % | 5-10 % |
| Function | JUELL Soft Cure | Ufi Gel SC |
|---|---|---|
| Monomer Matrix | 80 - 90 % | 80 - 90 % |
| Rheologic Modifier | 10 - 20 % | 10 - 20 % |
| Catalyst | 0,1 - 0,5 % | 0,1 - 0,5 % |
| Monomer Matrix | 60 - 70 % | 60 - 70 % |
| Rheologic Modifier | 20 - 30 % | 20 - 30 % |
| Stablizer | 8 - 15 % | 8 - 15 % |
| Function | JUELL Soft Cure | Ufi Gel SC |
|---|---|---|
| Monomer Matrix | 70 - 85 % | 70 - 85 % |
{2}------------------------------------------------
| 8- | ||
|---|---|---|
| r- | - | |
| f | -/ | |
| 1 |
| Rheologic Modifier | 15-20 % | 15-20 % |
|---|---|---|
| Stabilizer | 0,1 - 0,5 % | 0,1 - 0,5 % |
| Co-Monomer | 2-5% | 2-5% |
| Test Item | JUELL Soft Cure | Ufi Gel SC |
|---|---|---|
| Surface hardness(Shore hardness A) | 26.3 | 26.3 |
| Adhesion to dentures | 190 N | 190 N |
| Working time | 201 s | 201 s |
24.25
JuellCure Soft is substantially equivalent to Ufi Gel SC in regards to indications, composition, and testing results.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Juell Dental C/O Ms. Angela Blackwell Senior Consultant Biologies Consulting Group 2401 N Commerce Ardmore, Oklahoma 73401
SEP 12 2011
Re: K111178
Trade/Device Name: JuellCure Soft Impression Material Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining. Repairing. or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: August 30, 2011 Received: September 1, 2011
Dear Ms. Blackwell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however. that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{4}------------------------------------------------
Page 2 - Ms. Blackwell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRHis) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): _K111178
Device Name: JuellCure Soft Impression Material
Indications for Use:
JUELLCure Soft is indicated for use as a permanent soft relining for total and partial dentures: .
- to relieve pressure from pressure points -
- to dam the palatal vibrating line -
- in cases of flabby ridge and/or insufficient adhesion -
- to cushion sharp-edged alveolar processes
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Puma
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page of
510(k) Number: K111178
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.